MAUDE Adverse Event Report: ICU MEDICAL, INC. MEDEX IV FILTER EXTENSION SET; FILTER, INFUSION LINE

Catalog Number	FS116
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that the device's filter was leaking while it was used on the patient for an infusion.The leaking came from the seal between the filter and the line proximal to the patient.Nursing brought syringe and line back to change lines out, however tech could not draw fluid back from the in-line filter at all.After confirming with team that a reduced volume (about 1 ml per line) was ready to salvage therapy today, a technician attached a new in-line filter and primed as per standard compounding procedure for brineura.Same leaking happened immediately after starting infusion again.They discussed potentially to switch this new line lot instead which would result in a total of 2.5 ml total loss.The team agreed with reduced dose today in lieu of delaying therapy for days or another week.They confirmed that there was no issue with leaking with this new line.There was no medical intervention required.The outcome of the event was resolved and no patient harm was reported.
Additional Manufacturer Narrative
H2) device evaluation: h3, h6: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.

• Brand Name: MEDEX IV FILTER EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): ICU MEDICAL, INC.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22208134
• Report Number: 1526863-2025-00067
• Device Sequence Number: 20761797
• Product Code: FPB
• UDI-Device Identifier: 10351688510969
• UDI-Public: (01)10351688510969(17)261016(10)4431429
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FS116
• Device Lot Number: 4431429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/14/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown